SUVN-502
- Generic Name
- SUVN-502
- Drug Type
- Small Molecule
- Chemical Formula
- C21H24BrN3O3S
- CAS Number
- 701205-60-9
- Unique Ingredient Identifier
- 8XZ281AO3G
- Background
SUVN-502 is a novel, potent, safe, highly selective and orally active antagonist at a central nervous system serotonin receptor site 5-HT6 intended for treatment of cognitive disorders such as Alzheimer’s and Schizophrenia, an unmet medical need.
- Indication
Investigated for use/treatment in neurologic disorders.
Pipeline Analysis Reveals 20+ Therapies in Development for Open-Angle Glaucoma Treatment
• DelveInsight's latest report identifies 18+ companies developing 20+ therapeutic candidates for open-angle glaucoma, with several treatments advancing through late-stage clinical trials.
• Key players including Nicox, Qlaris Bio, and Glaukos Corporation are making significant progress with innovative treatments like NCX 470, QLS-111, and iDose TREX, demonstrating positive clinical outcomes.
• Novel drug delivery mechanisms, including sustained-release implants and encapsulated cell therapies, are emerging as promising approaches to address the challenges of treatment adherence and efficacy in glaucoma management.
Suven Life Sciences Initiates Phase 1 Trial of SUVN-I6107 for Cognitive Disorders
• Suven Life Sciences has dosed the first subjects in a Phase 1 clinical trial of SUVN-I6107 for cognitive disorders.
• The Phase 1 trial is a randomized, double-blind, placebo-controlled study to assess safety, tolerability, pharmacokinetics, and pharmacodynamics.
• SUVN-I6107 is a novel, potent, and selective muscarinic M1 positive allosteric modulator, showing efficacy in animal models.
• The trial is being conducted in the US under FDA acceptance of an Investigational New Drug application.
Cobenfy Shows Cognitive Benefits in Schizophrenia Patients with CANTAB Assessment
• Cobenfy, a novel schizophrenia treatment targeting M1/M4 muscarinic receptors, has received FDA approval and demonstrates efficacy in reducing both positive and negative symptoms.
• A post-hoc analysis of Phase 3 trials using Cambridge Cognition's CANTAB reveals cognitive performance improvements in schizophrenia patients with pre-existing cognitive impairment.
• The CANTAB assessment tool proves instrumental in tracking cognitive benefits, enhancing data collection, and accelerating the development of effective schizophrenia treatments.
• Cobenfy represents a breakthrough as the first monotherapy to demonstrate replicable cognitive benefits, independent of its impact on positive and negative symptoms.
Axsome's AXS-05 Shows Promise in Alzheimer's Agitation Trials, NDA Submission Planned for 2025
• Axsome Therapeutics' AXS-05 demonstrated a statistically significant delay in agitation relapse in Alzheimer's patients in the ACCORD-2 Phase 3 trial.
• The ADVANCE-2 trial did not meet its primary endpoint, but results numerically favored AXS-05, with a good safety profile across trials.
• Axsome plans to submit an NDA to the FDA in the second half of 2025, supported by data from four Phase 3 trials.
• AXS-05 has Breakthrough Therapy designation, potentially expediting its review for Alzheimer's disease agitation, a condition with limited options.
Neuroscience Drug Development: A Year of Highs and Lows in 2024
• The FDA approved Bristol Myers Squibb’s Cobenfy, the first novel schizophrenia treatment in 35 years, marking a significant triumph in neuroscience.
• Eli Lilly's donanemab (Kisunla) gained approval as the third anti-amyloid antibody for Alzheimer's, while Biogen discontinued Aduhelm to focus on Leqembi.
• Amylyx pulled Relyvrio from the market after it failed in Phase III trials for ALS, highlighting the challenges in neurodegenerative disease treatment.
• Rare neurological diseases saw progress with approvals for gene therapies and treatments for metachromatic leukodystrophy and Niemann-Pick disease type C.
Alzheimer's Disease Pipeline Shows Promise with 120+ Therapies in Development
• Over 120 Alzheimer's Disease treatment therapies are under development by 110+ companies globally, ranging from preclinical to marketed phases.
• Emerging therapies like NRDN-201, ST-501, and KarXT are in various clinical trial phases, showing potential for significant market impact.
• MapLight Therapeutics initiated a Phase 1 trial for ML-007/PAC, targeting schizophrenia and Alzheimer's disease psychosis, with Phase 2 trials planned.
• The FDA granted conventional approval to Leqembi (lecanemab-irmb), marking the first amyloid beta-directed antibody to transition from accelerated approval.
AbbVie's Emraclidine Fails, Bolstering BMS's Lead in Schizophrenia Treatment
• AbbVie's emraclidine failed to demonstrate statistically significant improvement in schizophrenia symptoms in Phase II trials, a setback for the muscarinic pathway approach.
• Bristol Myers Squibb's Cobenfy (KarXT), a muscarinic agonist, now stands as the frontrunner in schizophrenia treatment after AbbVie's trial failures.
• Neurocrine Biosciences is advancing NBI-1117568, an oral muscarinic M4 selective agonist, with Phase III trials planned for early 2025, showing a potential path forward.
• Other companies like Neumora Therapeutics and Reviva Pharmaceuticals are also exploring novel mechanisms for schizophrenia treatment, indicating a dynamic therapeutic landscape.
AbbVie's Emraclidine Fails Phase 2 Schizophrenia Trial, Boosting Bristol Myers Squibb's Cobenfy
• AbbVie's emraclidine did not meet the primary endpoint in a Phase 2 trial for schizophrenia, showing no statistically significant improvement over placebo.
• Analysts suggest this failure removes a major competitive threat for Bristol Myers Squibb's recently approved schizophrenia drug, Cobenfy (KarXT).
• Cobenfy, targeting M1/M4 receptors, is projected to reach over $5 billion in peak sales, potentially benefiting from emraclidine's setback.
• Neurocrine Biosciences may also benefit if its Phase 3 schizophrenia drug program succeeds, though the challenges in neurological drug development are significant.
Bristol Myers Squibb Soars as AbbVie's Schizophrenia Drug Fails Trial
• AbbVie's phase 2 trial of emraclidine for schizophrenia did not meet its primary endpoint, showing no statistically significant improvement over placebo.
• Bristol Myers Squibb's stock surged following AbbVie's announcement, driven by the potential expansion of Cobenfy's market opportunity.
• Cobenfy, a recently FDA-approved schizophrenia drug by Bristol Myers, offers a novel approach by selectively targeting M1 and M4 receptors.
• Analysts suggest AbbVie's setback provides Bristol Myers Squibb with a first-mover advantage in the schizophrenia treatment landscape.
AbbVie's Emraclidine Fails in Phase II Schizophrenia Trials, Shares Plummet
• AbbVie's emraclidine failed to demonstrate statistically significant improvement in schizophrenia symptoms compared to placebo in two Phase II trials.
• The failure led to a 12% drop in AbbVie's shares, raising concerns about the company's long-term growth strategy and neuroscience pipeline.
• Analysts highlight the surprisingly high placebo response in the trials, while others point to potential implications for the broader CNS drug development landscape.
• Bristol Myers Squibb's recently approved Cobenfy (KarXT) for schizophrenia may benefit from AbbVie's setback, potentially reaching peak sales of $4 billion.
Bristol Myers Squibb Soars as AbbVie's Schizophrenia Drug Fails Trial
• AbbVie's Phase 2 trial of emraclidine for schizophrenia did not meet its primary endpoint, showing no statistically significant improvement over placebo.
• Bristol Myers Squibb's stock surged by 12.5% following AbbVie's announcement, highlighting the competitive landscape in schizophrenia treatment.
• Cobenfy (KarXT), Bristol Myers Squibb's recently approved schizophrenia drug, represents a novel approach by selectively targeting M1 and M4 receptors.
• The failure of AbbVie's drug underscores the challenges in developing new treatments for schizophrenia and the importance of diverse therapeutic approaches.
Recent Advances in Small Molecule Therapies: FDA Approvals and Clinical Trial Updates
• The FDA approved Bristol Myers Squibb's Cobenfy for schizophrenia, marking the first new mechanism of action in over 50 years by targeting muscarinic acetylcholine receptors.
• Gilead Sciences has entered voluntary licensing agreements to expand access to lenacapavir, an HIV-1 drug with a novel mechanism, in resource-limited countries.
• AstraZeneca's Tagrisso received FDA approval for unresectable non-small cell lung cancer after demonstrating progression-free survival in the LAURA trial.
• Pfizer voluntarily withdrew Oxbryta, a sickle cell disease treatment, from all markets due to post-marketing clinical trials revealing a higher rate of vaso-occlusive crisis.
Bristol Myers Squibb Presents New COBENFY Data for Schizophrenia Treatment at Psych Congress
• Bristol Myers Squibb is presenting new data at Psych Congress highlighting the clinical profile of COBENFY (xanomeline and trospium chloride) for schizophrenia.
• Data from the EMERGENT clinical trial program demonstrates COBENFY's efficacy, safety, and patient-reported outcomes in adults with schizophrenia.
• Presentations include long-term safety and efficacy results, patient satisfaction, and quality of life improvements with xanomeline and trospium chloride.
• Additional research covers health economics, real-world data on negative symptoms and cognitive impairment, and comparative efficacy against atypical antipsychotics.
Suven Life Sciences' Ropanicant Shows Positive Phase 2a Results for Major Depressive Disorder
• Suven Life Sciences announced positive results from its Phase 2a proof-of-concept study of Ropanicant (SUVN-911) in patients with moderate to severe Major Depressive Disorder (MDD).
• Ropanicant, an α4β2 nicotinic acetylcholine receptor (nAChR) antagonist, demonstrated promising safety and efficacy outcomes in the open-label Phase 2a study.
• Suven plans to advance Ropanicant into a double-blind, placebo-controlled Phase 2b clinical study in MDD patients, anticipated to start in early 2025.
• The company will present these findings at the upcoming Neuroscience 2024 conference, highlighting its portfolio of new chemical entities.
Transcranial Magnetic Stimulation Shows Promise in Treating Multiple System Atrophy
• Transcranial magnetic stimulation (TMS) is explored as a non-invasive therapeutic strategy for multiple system atrophy (MSA), a rare neurological disorder with limited treatment options.
• Studies suggest TMS can modulate cerebral blood flow and influence the excitability of targeted cortical areas, impacting synaptic plasticity and brain functional connectivity.
• Research indicates TMS may improve motor and non-motor symptoms in MSA, including parkinsonism, ataxia, anxiety, and depression, by targeting the motor cortex or cerebellum.
• A multi-center, randomized, double-blind, sham-controlled study is underway to further evaluate the efficacy and mechanisms of TMS in treating MSA, addressing limitations of prior studies.
Obinutuzumab Shows Positive Results in Phase 3 Trial for Lupus Nephritis
• Genentech's phase 3 REGENCY trial of obinutuzumab (Gazyva) plus standard therapy met its primary endpoint, demonstrating a statistically significant complete renal response in patients with lupus nephritis.
• The study results support the potential of obinutuzumab as a valuable treatment option for lupus nephritis, addressing an unmet need in managing this severe manifestation of systemic lupus erythematosus.
• Genentech plans to submit the REGENCY trial data for publication and presentation at an upcoming scientific conference, further disseminating the findings to the medical community.
FDA Approves Cobenfy, a Novel Schizophrenia Treatment Targeting Cholinergic Receptors
• The FDA has approved Cobenfy (xanomeline and trospium chloride) as the first new class of drug for schizophrenia in over 30 years, offering a novel approach to treatment.
• Cobenfy targets muscarinic receptors, unlike traditional antipsychotics that focus on dopamine, potentially reducing side effects like weight gain and movement disorders.
• Clinical trials demonstrated Cobenfy significantly reduced schizophrenia symptoms compared to placebo, marking a transformative moment in managing this challenging condition.
• Expected to launch in late October, Cobenfy offers a new option for adults with schizophrenia, with ongoing studies exploring its potential in Alzheimer's psychosis and other conditions.
rTMS Shows Promise for Chronic Neuropathic Pain Relief in UCSF Study
• A UCSF study is evaluating repetitive transcranial magnetic stimulation (rTMS) as a treatment for chronic neuropathic pain, which affects a significant portion of the population.
• The research focuses on high-frequency rTMS applied to the motor cortex (M1), a region previously shown to benefit chronic neuropathic pain, to modulate brain activity.
• The study aims to identify patient characteristics predictive of responsiveness to M1 rTMS and explore alternative stimulation targets for non-responders using fMRI.
• rTMS, already FDA-approved for conditions like depression and migraine, offers a non-invasive approach to pain management, potentially circumventing the adverse effects of current treatments.
Drug Development Updates
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